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Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus

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Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus Journal of Gastrointestinal Surgery (2019) 23:982–989 https://doi.org/10.1007/s11605-018-4030-4 ORIGINAL ARTICLE Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus Anand Navalgund1 & Steve Axelrod1 & Lindsay Axelrod1 & Shyamali Singhal2 & Khoi Tran3 & Prithvi Legha 3 & George Triadafilopoulos4 Received: 6 July 2018 /Accepted: 22 October 2018 /Published online: 2 November 2018 # 2018 The Society for Surgery of the Alimentary Tract Abstract Background Passage of flatus after abdominal surgery signals resolution of physiological postoperative ileus (POI) and often, partic- ularly after complex open surgeries, serves as the trigger to initiate oral feeding. To date, there is no objective tool that can predict time to flatus allowing for timely feeding and optimizing recovery. In an open, prospective study, we examine the use of a noninvasive wireless patch system that measures electrical activity from gastrointestinal smooth muscles in predicting time to first flatus. Methods Eighteen patients who underwent open abdominal surgery at El Camino Hospital, Mountain View, CA, were consented and studied. Immediately following surgery, wireless patches were placed on the patients’ anterior abdomen. Colonic frequency peaks in the spectra were identified in select time intervals and the area under the curve of each peak times its duration was summed to calculate cumulative myoelectrical activity. Results Patients with early flatus had stronger early colonic activity than patients with late flatus. At 36 h post-surgery, a linear fit of time to flatus vs cumulative colonic myoelectrical activity predicted first flatus as much as 5 days (± 22 h) before occurrence. Conclusions In this open, prospective pilot study, noninvasive measurement of colon activity after open abdominal surgery was feasible and predictive of time to first flatus. Interventions such as feeding can potentially be optimized based on this prediction, potentially improving outcomes, decreasing length of stay, and lowering costs. Keywords Noninvasive wireless patch . Postoperative recovery . Colon myoelectrical activity . First flatus . Ileus . Open abdominal surgery Introduction complexity of the surgery, degree of bowel handling, and pre- operative comorbidities affecting whether the recovery hap- Gastrointestinal recovery after any visceral surgery is a com- pens over few days, or is a slow prolonged affair lasting plex dynamic process with multiple factors ranging from weeks.1 Delays in the gastrointestinal recovery process or ile- us are accompanied by distention of the abdomen, pain, nau- 2,3 Poster presentation The work was presented as a poster at the 2018 sea, vomiting, and the inability to tolerate oral feeding. Digestive Disease Week (DDW) held in Washington D.C, June 2018. Interventions to alleviate the ileus/distention include insertion or reinsertion of a nasogastric tube, instating nil per os and, if 4 * Anand Navalgund necessitated, parenteral nutrition. All of these factors contrib- [email protected] ute not only to patient discomfort, but extend length of stay (LOS), increase hospital resource utilization, and thereby add 5–7 1 G-Tech Medical, Fogarty Institute for Innovation, 2490 Hospital to overall costs. Drive, Suite 310, Mountain View, CA 94040, USA Clinically, the markers of gastrointestinal recovery are noted 2 El Camino Hospital, 2500 Grant Road, Mountain View, CA 94040, by passage of flatus, defecation, and the ability to tolerate solid USA food without significant nausea and vomiting.8 Passage of stool 3 Palo Alto Medical Foundation, Sutter Health, 701 E El Camino Real, or flatus—considered a surrogate for intestinal and anastomotic Mountain View, CA 9404, USA continuity—is often used as the trigger to start stepwise dietary 4 Department of Medicine, Division of Gastroenterology, Stanford orders with the patient’s ability to tolerate each step marking University School of Medicine, 300 Pasteur Drive, their readiness for the subsequent meal. Fast-track programs Stanford, CA 94305, USA J Gastrointest Surg (2019) 23:982–989 983 that promote early feeding in advance of these clinical markers Mountain View, CA. Patients were asked to self-report pas- have shown some success in reducing the incidence of ileus, sage of flatus, bowel movement, and intake of diet through a but not entirely. In a recent study of 513 consecutive colorectal smartphone app. In cases where the patients were not patients who were on an enhanced recovery after surgery smartphone savvy, information was logged for them through (ERAS) protocol, 128 patients (24.7%) needed postoperative daily rounds by the study coordinator. reinsertion of nasogastric tube at the 3.9 ± 2.9 postoperative day.9 This suggests that, while early postoperative feeding is Wireless Patch beneficial to patients in whom recovery is on track, it does not work in cases where they are not ready for it. Immediately following surgery, three disposable wearable At present, there is no reliable measurement that can pre- wireless patches (G-Tech Medical, Fogarty Institute for dict gastrointestinal recovery/diet readiness for patients in ad- Innovation, Mountain View, CA) that acquire myoelectrical vance of these clinical markers that may allow for interven- signals from the gastrointestinal tract were placed on the an- tions or fast-track programs to facilitate timely recovery. terior abdomen. Prior to patch application, the skin was pre- Auscultation for return of bowel sounds, long part of the stan- pared using isopropyl alcohol and NuPrep gel (Weaver and dard of care, is controversial in its usefulness to indicate re- Company, Aurora, CO, USA) to optimize the conductivity covery. Bowel sounds have shown to have poor correlation from skin to electrode and minimize variability between pa- with flatus/defecation and have proved unsuccessful in guid- tients. The variation in body size and tissue thickness between ing diet interventions.10,11 Some authors have recently argued patients was addressed by a compensation factor which uses for discontinuation of the practice.12 their body mass index and a patent-pending compensation Smooth muscle electrical activity on the other hand is di- algorithm that uses certain aspects of the acquired data itself rectly related to gastrointestinal function and motility. to arrive at the correction. Researchers have previously shown a 1:1 correlation between The G-Tech 6-day wearable patch (Fig. 1a) consists of a electrical and mechanical (contractile) events in the colon with flexible substrate material approximately 2.7″ diameter which internally placed electrode-strain gauge force transducers.13–15 is made up of Ag/AgCl electrodes, a medical grade adhesive, Electrical activity in the colon has been reported across a wide and electronics, to acquire, digitize, and transmit myoelectri- range of frequencies, ranging from 0 to 40 cycles per min cal data via Bluetooth Low Energy (BLE) to a paired iPod (cpm).16,17 Researchers have documented the progressive re- Touch App. The patch includes a 3-V CR2354 battery to turn of colonic electrical activity within these frequencies relat- power its electronics. These patches have a runtime of 6 days ed to resolution of postoperative ileus and clinical recovery and were replaced as needed until the patients’ discharge. The following surgery.16–18 These measurements have been per- custom app has a patient interface to enter clinical informa- formed using electrodes placed internally during surgery, a ma- tion, such as overall mobility, diet status, pain control, nausea jor impediment towards broader use of such technology. or emesis, and the return of bowel function. The application To overcome this limitation, we have developed a nonin- periodically uploads the raw data to a cloud server to be vasive wireless patch system that measures electrical activity downloaded and analyzed (Fig. 1b). The G-Tech system is from the gastrointestinal smooth muscles on the abdominal currently investigational. surface. We have previously reported on the co-occurrence of colon frequency peaks in the 12–28 cpm range in the elec- Processing of Myoelectrical Activity Data and Cohort trical activity with that of pressure recordings measured inter- Analysis nally in the colon via the SmartPill across a multitude of subjects.19 Herein, we examine the feasibility and usefulness Figure 2a shows an example of the raw data containing a burst of this measurement from the noninvasive wireless patch sys- of rhythmic colonic myoelectrical activity with the corre- tem in determining gastrointestinal recovery following open sponding frequency spectrum in Fig. 2b showing the peak abdominal surgery. for the rhythmic activity at ~ 20 cpm. Data processing was performed in a custom LabVIEW version 14.0.1 program and included removal of large amplitude artifacts and band- Methods pass filtering, followed by Fourier transformation to frequen- cy space over 10-min time intervals. Peaks in the frequency Patients and Clinical Parameters spectrum were identified in the 12–28 cpm range within each 10-min interval and the area under the curve (AUC) was cal- Nineteen patients who underwent open abdominal surgeries at culated. Cumulative colonic myoelectrical activity was then a community hospital were consented and enrolled in this trial calculated by summing over each 10-min interval the respec- between March 2016 and May 2017. The study was approved tive AUC multiplied by its duration. One
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